PODCAST: Williams Mullen's Trending Now: An IP Podcast - Cease and Desist Letters: Protecting Your Intellectual Property the Right Way
What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
3 Key Takeaways | What Corporate Counsel Need to Know About Patent Damages
Patent Litigation: How Low Can You Go?
(Podcast) The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Briefing: Netflix to Pay $2.5M to GoTV for Patent Infringement
The Art of Teaching Complex Technology in Patent Litigation - IMS Insights Podcast Episode 67
The Briefing: Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
Podcast: The Briefing - Failure to Disclose Relationship with Real Party in Interest Results in Serious Sanctions
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Estoppel Doctrine in China's Patent System
Donation (Disclosure-Dedication) Doctrine in China’s Patent Litigation
6 Key Takeaways | Patent Opinions – New Developments and Pitfalls
Patent Right Evaluation Report in China’s Patent System
Kidon IP War Stories: David Cohen & Daryl Lim
Protecting the PB&J – Preserving IP Rights from Concept to Market
Patent Marking in China
The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more
In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more
The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more
In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more
A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more
The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of...more
On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation - As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics,...more
ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more
The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more
Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor...more
Are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, protected under the Hatch-Waxman safe harbor? While courts have reached different...more
On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
The federal government’s ability to compel manufacture of supplies under the Defense Production Act has lately been in the news. Indeed, President Trump has issued an Executive Order authorizing the Secretary of Health and...more
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that ruling upheld a jury verdict...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
PATENT CASE OF THE WEEK - Blackbird Tech LLC v. Health in Motion LLC, Appeal No. 2018-2393 (Fed. Cir. Dec. 16, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a fee award against prevailing...more
On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more